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Pelvital USA, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K240805Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)August 1, 2024
K233362Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)December 29, 2023
K212655FlyteSeptember 21, 2021
K210764FlyteApril 13, 2021
K200409Pelvital SystemJuly 10, 2020